NUFLOR GOLD- florfenicol injection
Injectable Solution, An Antimicrobial
For subcutaneous use in beef and non-lactating dairy cattle only
Not for use in female dairy cattle 20 months of age or older or in calves to be processed for veal
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
NUFLOR GOLD™ is an injectable solution of the synthetic antibiotic florfenicol. Each milliliter of sterile NUFLOR GOLD™ contains 300 mg of florfenicol, 300 mg of 2-pyrrolidone, and triacetin qs.
NUFLOR GOLD™ is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.
DOSAGE AND ADMINISTRATION
NUFLOR GOLD™ should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight (6 mL/100 lb). Do not administer more than 15 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated.
|NUFLOR GOLD™ Dosage Guide|
|100||6.0||Recommended Injection Location:|
Do not use in animals that have shown hypersensitivity to florfenicol.
NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains materials that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.
For customer service, to report suspected adverse reactions, or to obtain a copy of the MSDS, call 1-800-211-3573.
Not for use in animals intended for breeding purposes. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.
Subcutaneous injection in cattle can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.
Animals intended for human consumption must not be slaughtered within 44 days of treatment. Do not use in female dairy cattle 20 months of age or older. Use of florfenicol in this class of cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.
Transient inappetence, diarrhea, decreased water consumption, and injection site swelling have been associated with the use of florfenicol in cattle. In addition, anaphylaxis and collapse have been reported post-approval with the use of another formulation of florfenicol in cattle.
The pharmacokinetic disposition of NUFLOR GOLD™ was evaluated in feeder calves following a single subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight. Administration of NUFLOR GOLD™ resulted in florfenicol plasma concentrations of 2 µg (mcg)/mL within two hours of injection.
|Cmax (µg/mL)||Tmax (hr)||AUClast (µg*hr/mL)||T½(hr)|
|Cmax : Maximum observed plasma concentrationTmax : Time at which Cmax was observedAUClast : Area under the plasma-concentration-time curve from time zero to the last quantifiable concentration that is equal to or greater than the limit of quantification of the validated analytical methodT½ : Terminal elimination half-life% CV: Percent coefficient of variance|
|Figure 1. Mean Florfenicol Plasma Concentration versus Time Following a Single Subcutaneous Injection of NUFLOR GOLD™ at a Dose Rate of 40 mg Florfenico/kg Body Weight in Feeder Calves (Mean ± Standard Error of the Mean)|
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